The Hackensack Meridian Health Center for Discovery and Innovation may be less than a week away from getting federal approval to use a test it has created to detect the rapidly growing coronavirus or COVID-19, ROI-NJ has learned.
The test, developed by a team led by Dr. David Perlin, the chief scientific officer at CDI, is in the process of being validated, Perlin said.
If validation is complete — and Perlin is hopeful that will be the case by the middle of next week — the test will be sent to the Food & Drug Administration for approval for emergency use.
Perlin feels the test not only is superior to the two tests most commonly used today, but it will help those diagnosed in New Jersey, as it will speed up the time of their diagnosis — potentially from days to hours — and thus speed up the onset of treatment. It also will help identify patients who do not have the virus, easing anxiety.
The need for more testing is obvious. On Friday, the number of confirmed cases of COVID-19 went over 100,000 globally. In New Jersey, a third case was diagnosed. New Jersey’s first known case was diagnosed on Wednesday.
Perlin said the test currently is being validated at a CLIA-certified molecular lab at Hackensack University Medical Center. On Friday, the CDI received the live virus, a major step that helped bring the test closer to the finish line for use in the hospital setting.
“We’re training personnel there,” Perlin said. “We’re now in the process of validating the test according to what the FDA has asked us in terms of the validation for clinical application. This will allow us to then request emergency use authorization.
“Once we feel the test meets all the clinical criteria — and that should happen in the next few days — the intent is to then notify the FDA and request authorization to use this under emergency use.”
Perlin said there are no shortcuts to validation.
“I like to be pragmatic about this,” he said. “I’ll be happy if, by the middle of next week, we can finalize. It all has to be analyzed and we need third parties to look at it and make sure that everybody agrees that it meets the criteria. That’s the only way I operate. It has to be at the very highest standard. I’d rather take an extra day and make sure we get it right.”
Perlin said the expects the FDA would act quickly.
“The FDA has said, ‘If you get those to our hands, we will try to turn it around within a day,’” he said. “But it’s going to depend on how many people are submitting. And, right now, I think they’re getting a number of applications.”
Should it be approved, Perlin said CDI would help others use the test.
“It is 100% transferable,” he said. “We built the test so that others could use it, that we can roll it out further in our system and to others.
“We’re here to try to improve clinical outcomes. And the only way to do that is to diagnose early and accurately. That’s the test that we built and, if others need to use it, we’ll be happy to provide them with all or everything that’s required to run this test. And, then, if they need training, they can come here — we’ll train them.”
Perlin is one of the leading infectious disease experts in the world. Back in 2003, he said he was asked by the Chinese government for help with the SARS epidemic. He was not asked for assistance with this epidemic, but his team began searching for solutions around the new year.
Perlin has run CDI since it officially opened last May. He said the creation of this test is what the center was designed to do.
“This is why the CDI was created,” he said. “It was created to take people who are doing really innovative science and translate it very rapidly for clinical application. This is what we do.
“This is a complete validation of the concept that HMH CEO Bob Garrett had in mind when he said, ‘Let’s make science work for our patients.’ That’s why I came here and that’s what I want to do.”
Perlin said the significance is huge.
“You (can’t) overstate it,” he said. “This is something that we’ve done for the last two decades in developing molecular diagnostic tests for hospitals, for outbreaks, for CDC, for all sorts of people. That is what we do.
“We developed a specialized task, which in our view is superior to the CDC test. Others can make that assessment, but we believe it’s superior for a variety of reasons, some of which have already been presented in the media with some of the deficiencies of the CDC test. We wanted to prepare ourselves for the fact that we needed a high-quality test that was extremely reliable. That’s what we developed.”
The following are more questions and answers from Perlin’s interview with ROI-NJ. They were edited and condensed in some areas for clarity:
ROI-NJ: Talk about the test you’ve developed and where it stands?
David Perlin: Our test is an expanded version of the CDC test. It uses some of the key elements of the CDC test and combines those with other key elements of the test that was developed in Germany and has been adopted by the (World Health Organization). We feel that it has some superior qualities to it. We’re in the process of validating now for submission to the FDA for emergency use authorization.
ROI: When you say ‘in the process of validating,’ what does that entail?
DP: For any test for use under emergency use authorization, you need to be able to show that the test has performance characteristics that warrant it as a reliable diagnostic to test what it is that you want — in this case, the COVID-19 virus. That’s what we’re in the process of doing.
On Monday, we received additional guidance from the FDA about what they were looking for in that sort of validation.
ROI: If you got authorization, for example, on Monday morning at 9 a.m., you would then do what? How would this roll out?
DP: The way we’re intending to use it initially is to have the testing capability within our own facility at a single site (at the molecular lab at Hackensack University Medical Center). And then, depending on the need, we could then we could then roll out the testing platform to other sites.
It’s not quite as simple as it sounds because there are specific equipment needs, there’s training. We’re in the process of doing all those things with the anticipation, potentially, that we might have to expand our testing depending on the patient load and depending on what happens with the spread of the virus in our area, which we just don’t know right now.
We’re taking the tack that we have to plan for the worst. You always hope for the best, but you plan for the worst. We want to be prepared in the event that we need to do widespread testing.
ROI: Would there be a rush for widespread testing if this is approved?
DP: Despite what we’ve heard from Washington, ‘Go get tested,’ that’s not the way it’s going to play. There are clinical criteria, which CDC has established, which we, as a network, adhere to. We may expand those or contract them, depending on what we feel is medically necessary. But what you don’t want is for reams of people showing up to be tested because they don’t feel well. There has to be threshold values that are assessed, and which are clinical parameters that we would use essentially for any sort of testing. And, quite honestly, right now, that’s the way it’s set up, which is probably appropriate.
ROI: Talk us through how it was be determined if someone needed to be tested.
DP: If a person presents with what you feel is respiratory distress or they’re having problems breathing and they have clinical characteristics that might mimic or actually be related to a COVID-19 infection, you would put them through a normal respiratory panel.
The CDC relaxed their original criteria, which was far more stringent than that. They’ve relaxed it to basically say if patients present with acute lower respiratory distress, and had no other ideological agent that was the cause of the infection, meaning they didn’t have the flu, that they didn’t have some bacterial infection, they would then be a candidate for testing.
We would do something very similar. Unless we had a situation like in 2009, the H1N1 flu pandemic, where fundamentally so many people were affected that basically the CDC said, ‘Stop testing, just assume anyone know presenting now has it.’ But, honestly, that’s not what we’re talking about. That’s not where we’re at or even approaching. So, that’s not what we’re talking about. What we’re talking about is a situation right now where patients who are presenting, who meet clinical criteria, which have been pretty clearly defined, would then be candidates.
ROI: Where would this testing be housed?
DP: The testing would be done in a CLIA-certified laboratory, which, right now, we’ve identified (as) the molecular lab at Hackensack University Medical Center. That’s where all the testing would be done. We want these to be proper clinical tests.
ROI: So, if someone comes to any HMH facility, that information needs to get to Hackensack University Medical Center to run the test?
DP: For now. That’s correct. Yes.
ROI: Why is it so important for HMH to be able to do its own testing?
DP: It’s important for any hospital group that is going to see a lot of patients, because it really becomes almost a triage tool. So, if you have a patient who presents, rather than waiting for the state labs, which might take a day to test and then, if it’s positive, it goes to the CDC for confirmation, you have this test. This way, within a few hours, we can get a positive or negative, and that helps us manage the patient.
It helps our health care staff assess what they need to do in terms of managing the patient. Are they going to be kept in isolation? Are they going to be kept in negative pressure rooms? Have they potentially had any exposure, and is that something that they need to watch out for? So, all of this is about the health care infrastructure. It’s about patient management. What we want to do is have more control over what’s happening with patients in our network.
ROI: So, you’re not necessarily taking state and federal bodies out of the process, you are just adding a layer that helps expedite it?
DP: That’s 100% correct. We don’t want to take out the public health authorities on this. We would notify the Department of Health that we have a positive. They may request to send the specimen to us. They may want to do their own testing, as may the CDC. We’re trying to get clarity on the progression. But, from a patient management standpoint, if our in-house test, which is FDA-approved for the emergency use authorization, is positive, we’re going to treat that patient as positive.
ROI: How much time are you saving?
DP: I don’t know what that turnaround time from the point the specimen is taken and then sent to the state lab is. It’s at least a day or two. Initially, it was three days, and, to the CDC, it was three to seven days. It’s certainly not a matter of hours, which is what we’re talking about.
The difference has to do with the gap between when you when you have identified the patient as suspect, you’re now taking a clinical specimen and now you need to determine what’s in it. And that’s where the gap is right now. Right now, it can be days. We don’t want it to be days; we can speed that up. And, so, whether the specimen came from our hospital bed two floors above or it was driven to us 30 minutes away from one of our hospitals, once we get it, we can process it very rapidly.
ROI: What do you need to conduct the test?
DP: It will almost certainly depend on the patient and what they’re presenting with. If they’re in severe respiratory distress on a respirator, most likely what they’re sending is some type of respiratory fluid. It might be a swab from the nose or from the throat. That’s the more typical sample that is sent these days. But, again, it’s going to depend on the individual patient.
ROI: Do you see any difficulty in getting a sample?
DP: For respiratory specimens, which we manage all the time, it’s not like this is unique. Respiratory swabs are pretty standard. You do a swabbing, you put it into a solution for transfer to the laboratory and then it’s processed within the laboratory. It’s a pretty straightforward process.
ROI: Much has been made about the cost of such tests. Will that be a factor?
DP: It comes into play. It’s not so much the reagent costs — or the individual components that are needed for the test itself. Those costs are not terribly expensive. The biggest cost is the labor cost. There is a larger issue here, and that’s now you’re dealing with a transmissible agent — you need people properly trained; you’re basically carving out a whole separate function for this.
ROI: Give us a timeline. When did you first start working on this?
DP: When this virus first started being reported in late December and we started seeing cases pop up in January, internally we began talking about, ‘Maybe we should really be thinking about a diagnostic for this.’ As we started seeing cases mount and understanding the way epidemic curves develop in the caseload, the way they were starting to ramp and the description of the virus, we said by mid-January, ‘Let’s start working on a molecular diagnostic.’
The first place we turned was to the CDC. I’ve worked with the CDC for many years and I have lots of close colleagues there. We’ve done a lot of really good things together. So, we went onto their website, which said, if you have molecular capability in-house, here’s what we recommend in terms of building the diagnostic for this. So, we did that, from the guidance that was provided by the CDC.
We started looking at that test, realized it had some deficiencies. A good test, but it wasn’t perfect. We also in parallel saw that a test was being developed by a very prominent coronavirus group in Germany. We started looking at those elements. We then married some of them together, tested it and decided on a testing platform, which we believe could deliver exactly what we need in terms of performance.
We had the test more or less completed in our laboratory where we were using synthetic templates. By the first or second week of February, we believed that, within the lab, we had a test that was very much ready to go and needed to be validated for clinical application.